NCT07179731

Brief Summary

This study aims to compare the efficacy of Subcostal Transversus Abdominis Plan Block, External Oblique Intercostal Plan Block and the combination of these two blocks, which are used in anesthesiology practice for postoperative pain in laparoscopy cholecystectomy surgery.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
105

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2025

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 31, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 18, 2025

Completed
5 days until next milestone

Study Start

First participant enrolled

September 23, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 10, 2025

Completed
21 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

September 18, 2025

Status Verified

July 1, 2025

Enrollment Period

3 months

First QC Date

July 31, 2025

Last Update Submit

September 17, 2025

Conditions

Keywords

external oblique intercostal blocksubcostal transverse abdominis block

Outcome Measures

Primary Outcomes (1)

  • Postoperative Analgesic Consumption

    The opioid consumption via patient controlled analgesia (PCA) in 24 hours postoperatively

    24 hours postoperatively

Secondary Outcomes (1)

  • Postoperative Pain Scores

    up to 24 hours after surgery

Study Arms (3)

Group 1: subcostal transversus abdominis plane block

ACTIVE COMPARATOR

This group will receive 30 ml 0.25% of bupivacaine for the subcostal transversus abdominis plane block prior to surgery.

Procedure: subcostal transversus abdominis plane block

Group 2: external oblique intercostal plane block

ACTIVE COMPARATOR

This group will receive 30 ml 0.25% of bupivacaine for the external oblique intercostal plane block prior to surgery.

Procedure: External Oblique Intercostal Plane Block

Group 3: subcostal transversus abdominis and external oblique intercostal plane block combination

ACTIVE COMPARATOR

This group will receive 15 ml 0.25% of bupivacaine for the external oblique intercostal plane block, in combination with 15 ml 0.25% of bupivacaine for the subcostal transversus abdominis plane block prior to surgery.

Procedure: external oblique intercostal plane block and subcostal transversus abdominis plane block combination

Interventions

Under ultrasound guidance, 30 ml of bupivacaine is injected along the fascia of transversus abdominis muscle.

Group 1: subcostal transversus abdominis plane block

Under ultrasound guidance, 30 ml of bupivacaine is injected between the fascias of external oblique and intercostal muscles.

Group 2: external oblique intercostal plane block

The combination of the two blocks will be applied in 15 ml of volume for each.

Group 3: subcostal transversus abdominis and external oblique intercostal plane block combination

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients scheduled for laparoscopic cholecystectomy surgery
  • Patients aged between 18 to 80 years
  • Having an anesthesiology risk assessment of ASA I, II, or III

You may not qualify if:

  • Patients who do not give written and oral consent
  • Patients with coagulopathy
  • History of allergic reaction or intoxication by local anesthetics
  • Severe organ failure
  • Mental retardation or illiteracy
  • Presence of infection on the injection site
  • Pregnancy
  • Patients whom the procedure is extended to open cholecystectomy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

July 31, 2025

First Posted

September 18, 2025

Study Start

September 23, 2025

Primary Completion

December 10, 2025

Study Completion

December 31, 2025

Last Updated

September 18, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share